Food Effect on Pharmacokinetic Parameters of ABX464

Healthy Volunteers Clinical Trial

Official title:

An Open, Randomized Study, to Investigate the Potential Food Effect on Pharmacokinetic Parameters of ABX464 Administered Orally to Healthy Male Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02731885
• Other study ID #: ABX464-FE-001
• Status: Completed
• Phase: Phase 1
• First received: March 25, 2016
• Last updated: April 4, 2016
• Start date: September 2014
• Est. completion date: June 2015

Study information

• Verified date: April 2016
• Source: Abivax S.A.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Mauritius: Ministry of Health and Quality of Life
• Study type: Interventional

Clinical Trial Summary

The goal of this study is to determine the impact of the food on the absorption of the ABX464.

Description:

This is a phase I, single-center, open-label, two-treatment, food-effect, randomized study in 40 healthy Caucasian male subjects in order to determine the impact of the food on the absorption of the ABX464.

The two different treatments are the followings:

• Treatment A = 50mg of ABX464 (two 25mg capsules) /Fasted

• Treatment B = 50mg of ABX464 (two 25mg capsules) / Fed

This study consists of two groups:

• Group 1 - single dose assessments, two-period, two-treatment, cross-over: 20 subjects will receive a single dose of 50mg of ABX464 in fed and fasted condition, separated by a wash-out period of at least 45 days.

• Group 2 - multiple dose assessments: 20 subjects will receive 50mg of ABX464 every 3 days during 10 days in fasted or fed condition.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• Healthy Caucasian male subjects, 18-55 years of age

• Body Mass Index (BMI) of 17-28 kg/m².

• Certified as healthy by a comprehensive clinical assessment (detailed medical history and complete physical examination)

• Normal vital signs after 10 minutes resting in supine position:

90 mmHg < systolic blood pressure < 140 mmHg, 50 mmHg < diastolic blood pressure < 90 mmHg, 40 bpm < heart rate < 100 bpm.

• Normal automatic 12-lead ECG (incomplete right bundle branch block can be accepted) or judged as non clinically significant.

• Clinical laboratory tests (hematology, blood chemistry, and urinalysis) must be within normal limits or clinically acceptable to Investigator and Sponsor.

• Subjects must be willing to give written informed consent prior to study enrollment and be able to adhere to restrictions and examination schedules.

Exclusion Criteria:

• Individuals with a history of any significant medical disorder which requires a physician's care (cardiovascular, pulmonary, gastro-intestinal, hepatic, renal, metabolic, hematological, neurologic, psychiatric, systemic, or infectious disease; any acute infectious disease or signs of acute illness)

• Frequent headaches and / or migraine, recurrent nausea and / or vomiting (more than twice a month).

• Presence or history of drug allergy, or allergic disease diagnosed and treated by a physician.

• Individuals who have a history of any clinically significant local or systemic infectious disease within 4 weeks prior to drug administration.

• Any individual who does not comply with the requirement that he should not have used any drugs other than paracetamol for at least 2 weeks prior to the study nor alcohol within 48 hours prior to drug administration.

• Individuals who are positive for hepatitis B virus, hepatitis C virus or HIV.

• History or presence of drug or alcohol abuse (positive urine drug screen, positive alcohol breath test).

• Smoking more than 5 cigarettes or equivalent / day, unable to stop smoking during the study.

• Excessive consumption of beverages with xanthine bases (> 4 cups or glasses / day).

• Subject who will likely be unable to eat entirely the standard high fat breakfast within the allocated time.

• Individuals who have donated blood within the preceding 3 months.

• Individuals who refuse to use an effective method of contraception from the beginning of the study and until 3 months after dosing.

• Individuals with forfeiture of freedom by an administrative or legal obligation or under guardianship

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• ABX464 Single dose
Two-periods, subjects received a single dose of 50mg of ABX464 in fed and fasted condition, separated by a wash-out period of at least 45 days.
• ABX464 Repeated dose
Subjects received 50mg of ABX464 every 3 days during 10 days in fasted or fed condition.

Locations

Country	Name	City	State
Mauritius	CAP Research	Sayed Hossen road	Phoenix

Sponsors (1)

Lead Sponsor	Collaborator
Abivax S.A.

Country where clinical trial is conducted

Mauritius, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area under the plasma concentration versus time curve (AUC) of single oral dose of 50mg of ABX464 in fed or fasted condition.		45 days	No
Primary	Peak Plasma Concentration (Cmax) of single oral dose of 50mg of ABX464 in fed or fasted condition.		45 days	No
Secondary	Area under the plasma concentration versus time curve (AUC) of repeated doses of 50 mg of ABX464 in fed or fasted conditions		10 days	No
Secondary	Peak Plasma Concentration (Cmax) of repeated doses of 50 mg of ABX464 in fed or fasted conditions		10 days	No
Secondary	Number of Subjects with treatment-related adverse events as assessed by CTCAE v4.0		Up to 45 days	Yes